Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data taken from IUCLID4 report with no information on methods or GLP status.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Method FDA modified followed
GLP compliance:
not specified
Type of assay:
rodent dominant lethal assay

Test material

Constituent 1
Chemical structure
Reference substance name:
1-bromo-3-chloropropane
EC Number:
203-697-1
EC Name:
1-bromo-3-chloropropane
Cas Number:
109-70-6
Molecular formula:
C3H6BrCl
IUPAC Name:
1-bromo-3-chloropropane

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Methylcellulose
Duration of treatment / exposure:
Once daily
Frequency of treatment:
5 days/week for 10 weeks
Doses / concentrations
Remarks:
Doses / Concentrations:
25 mg/kg; 75 mg/kg and 125 mg/kg bodyweight
Basis:

No. of animals per sex per dose:
3 groups of 10 males
Control animals:
yes
Positive control(s):
Triethylenemelamine was given as a positive control orally to a group of 10 male rats at a dose of 0.05 mg/kg.

Examinations

Tissues and cell types examined:
The test article did not produce dominant lethal effects in the male rats at the doses administered as measured by pre-implantation and post-implantation losses.
Evaluation criteria:
Dominant lethal effects were seen in the positive control group as a significant increase in post-implantation deaths.

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Under the conditions of this test, 1-bromo-3-chloropropane was not considered as mutagenic.